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January 30, 1978

A Calm Look at 'Drug Lag'

Author Affiliations

From the Food and Drug Administration, Washington, DC.

JAMA. 1978;239(5):423-426. doi:10.1001/jama.1978.03280320039017

IN RECENT testimony to a Senate subcommittee seeking ways to improve the drug regulation process in the United States, I insisted that an essential element in the updating of our drug laws must be the enhanced ability to expedite the approval of important therapeutic advances.

The Food and Drug Administration's responsibility to the public health is often thought of primarily as a matter of guaranteeing safety, but consumers are poorly served when they are denied access to safe products that are effective in the relief of pain or the cure of disease. We must view our role as regulators of technology transfer comprehensively and be just as conscious of the costs of foregone innovation as we are of other kinds of costs.

The view that we are not as conscious of these costs as we should be is widespread, especially among our critics in the drug industry. They have coined